Most women with pre-existing migraine will have no significant change from baseline headache frequency or clinical impact attributable to HC at 3 months following initiation; a minority will report clinically significant worsening or improvement

The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users

There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.

Initiating or using non-hormonal contraception or not using contraception

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Health female adults, patients of Planned Parenthood League of Massachusetts

Criteria

Inclusion Criteria:

Proficiency in English

Medically eligible for her chosen form of contraception per standard PPLM clinic protocol

(For Study Arm A) Desire initiation of an estrogen/progesterone contraceptive method at time of clinic presentation and evaluation

(For Study Arm B) Desire initiation of a progesterone only contraceptive method at time of clinic presentation and evaluation

(For Control Arm) Initiating a non-hormonal contraceptive, or not initiating any contraceptive method

(For Control Arm) Stated intention of not initiating any hormonal contraception over the 3 month study period

Agreeing to study procedures

Exclusion Criteria:

Inability to speak and read English

(For Control Arm) Use of hormonal contraceptive in the past 3 months

(For Control Arm) Been pregnant in the past 3 months

States an intention to discontinue use of their newly initiated contraceptive (or lack of contraceptive) before the end of the 3 month study period

Unwilling or unable to comply with study follow-up procedures

Inability to give informed consent

Previous participation in this study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216358